Ofloxacin

Product NDC
70518-3573
11-digit product format
705183573
Labeler code
70518
Product ID
70518-3573_f0d42247-a8cd-652a-e053-2a95a90a0b14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA076622
Marketing category
ANDA
Marketing start
2022-11-07
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3573OFLOXACIN SOLUTION/ DROPS [REMEDYREPACK INC.]3Legacy NDC20240116_38d0bbce-58ca-4fc1-a887-87b61fef9a87.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3573-0705183573001 BOTTLE, DROPPER in 1 CARTON (70518-3573-0) > 5 mL in 1 BOTTLE, DROPPER2022-11-070000-00-00NoNoCurrent